For the product release of new drugs or biologics, several tests are required from regulatory guidelines to ensure their quality. Cell lines must be authenticated, gene sequences must be confirmed, the identity of the plasmids used should be verified, and raw materials, cell lines and final products should be checked for mycoplasma and viral contaminations.
BaseClear solutions for product release & quality control
BaseClear supports its clients for performing molecular quality control of drugs, probiotics and other health promoting products. BaseClear can help you ensure that your products are not contaminated, and also that the correct microbial strains are present. BaseClear offers solutions to determine the presence/absence of DNA & viable cell counts in final product & release, e.g. needed for enzyme powders and beers.
BaseClear can help you perform these tests in compliance with your quality system. These services can be either ISO or GMP compliant. We can assist you in designing an optimal testing strategy for your production process.
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Get in touch with the BaseClear experts to discuss your specific project.